Expanding Plunger Rods for Syringes

ABSTRACT

An expanding plunger rod for a syringe is configured to transition from a packaged configuration to an expanded configuration for operation. The rod includes a substantially cylindrical outer sleeve having a closed-off bottom end and an open upper end, and an inner rod having a lower end and an upper end. The inner rod is slidably disposed coaxially within the outer sleeve. In the packaged configuration, the inner rod is nested within the outer sleeve. In the expanded configuration, the inner rod is disposed substantially axially above the outer sleeve, and the inner rod locks axially in place to prevent transition from the expanded to the packaged configuration.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of U.S. Provisional PatentApplication No. 61/935,081 filed Feb. 3, 2014.

FIELD

THIS INVENTION relates to syringes. More particularly, this inventionrelates to expanding plunger rods for syringes, the syringesincorporating such plunger rods, and the use of such syringes for thedelivery of fluids.

BACKGROUND

The practice of sharing syringes without adequate sterilization betweensuccessive users is a major contributor to the transfer of HumanImmunodeficiency Virus (HIV) and Hepatitis with subsequent severerepercussions for the sufferer and at a high cost to society forsupporting and providing medical attention to sufferers. Furthermore,health professionals may be exposed to used syringes which can lead toinadvertent needlestick injuries and possible exposure to infectivepathogens or other contaminants.

Additionally, today's healthcare practitioner is usually provided withmedical devices that are ready to use since the devices are typicallysterilized during manufacture. This is particularly true of syringesthat are used to administer parenteral drugs and other medicalsolutions.

A syringe typically includes a glass or plastic barrel having asubstantially closed end and an opposite open end. The open end issealed by a slidable piston plunger. The substantially closed end of thesyringe may have a dispensing port communicating with a fitment, such asa male luer fitment, for dispensing the contents of the syringe. Thesyringe as manufactured may be prefilled with a liquid, part-filled witha lyophilized powder, or empty, for example. A removable end cover orcap, such as a luer cap, is placed over the fitment during manufactureso as to seal the contents within the barrel. Thus, the end cap remainssealingly in place from manufacture until the syringe is used.

The packaging of syringes may require larger dimensions than necessaryor desirable, because the dimensions of such syringes for operation maybe larger than the desired packaged dimensions. When packaging syringesto be shipped or stored, it is important to conserve packing space toincrease the number of prefilled syringes shipped per package.

SUMMARY

The invention is, at least in part, broadly directed to a syringe havingan expandable plunger rod component capable of having a smallerdimension in packaging and a larger dimension for operation.

In one aspect, the disclosure describes an expanding plunger rod for asyringe. The expanding plunger rod is configured to transition from apackaged configuration for packaging to an expanded configuration foroperation. The expanding plunger rod comprises a substantiallycylindrical outer sleeve having a closed-off bottom end and an openupper end. The expanding plunger rod includes an inner sleeve having alower end and an upper end. The inner sleeve is slidably disposedcoaxially within the outer sleeve. The expanding plunger rod alsoincludes an inner rod having a lower end and an upper end. The inner rodis slidably disposed coaxially within the inner sleeve. In the packagedconfiguration, the inner sleeve and the inner rod are both nested withinthe outer sleeve. In the expanded configuration, the upper end of theinner sleeve and the lower end of the inner rod are both disposedaxially above the open upper end of the outer sleeve, and the innersleeve and inner rod are configured to lock axially in place so as toprevent transition from the expanded configuration to the packagedconfiguration.

In another aspect, the disclosure describes a syringe assemblyconfigured to transition from a packaged configuration for packaging andan expanded configuration for operation. The syringe comprises asubstantially cylindrical barrel having a plunger end and a connectionend. The syringe includes a plunger seal disposed within the plunger endof the barrel. The syringe includes a needle seal disposed within theconnection end of the barrel. The syringe includes a fluid compartmentdefined within the barrel between the plunger seal and the needle seal.The syringe also includes an expanding plunger rod comprising asubstantially cylindrical outer sleeve having a closed-off bottom endconnected to the plunger, and an open upper end. The expanding plungerrod includes an inner sleeve having a lower end and an upper end, theinner sleeve being slidably disposed coaxially within the outer sleeve.The expanding plunger rod also includes an inner rod having a lower endand an upper end, the inner rod being slidably disposed coaxially withinthe inner sleeve. The outer sleeve of the expanding plunger rod may beengaged with the plunger seal. The engagement may be in the form of athreaded engagement or other engagement known in the art. In thepackaged configuration, the inner sleeve and the inner rod are bothsubstantially nested within the outer sleeve. In the expandedconfiguration, the upper end of the inner sleeve and the lower end ofthe inner rod are both disposed axially above the open upper end of theouter sleeve, and the inner sleeve and inner rod are configured to lockaxially in place so as to prevent transition from the expandedconfiguration to the packaged configuration.

In another aspect, the disclosure describes an expanding plunger rod fora syringe, the expanding plunger rod configured to transition from apackaged configuration for packaging to an expanded configuration foroperation. The expanding plunger rod comprises a substantiallycylindrical outer sleeve having a closed-off bottom end and an openupper end. The expanding plunger rod includes an inner sleeve having alower end and an upper end, the inner sleeve being slidably disposedcoaxially within the outer sleeve. The expanding plunger rod includes aninner rod having a lower end and an upper end, the inner rod beingslidably disposed coaxially within the inner sleeve and including a toppiece extending axially above the open upper end of the outer sleeve.The expanding plunger rod may include a biasing member disposed betweenthe top piece of the inner rod and the closed-off bottom end of theouter sleeve. The biasing member biases the top piece and the bottom endaxially away from one another. In the packaged configuration, the innersleeve and the inner rod are both nested within the outer sleeve, and inthe expanded configuration, the upper end of the inner sleeve and thelower end of the inner rod are both disposed axially above the openupper end of the outer sleeve, and the inner sleeve and inner rod areconfigured to lock axially in place so as to prevent transition from theexpanded configuration to the packaged configuration. The biasing memberis configured to automatically transition the expanding plunger rod fromthe packaged configuration to the expanded configuration.

Throughout this specification, unless otherwise indicated, “comprise”,“comprises” and “comprising” are used inclusively rather thanexclusively, so that a stated integer or group of integers may includeone or more other non-stated integers or groups of integers.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting embodiments of the invention are described herein withreference to the following drawings wherein:

FIG. 1A shows an isometric view of a syringe having an expanding plungerrod in a packaged configuration, according to at least one embodiment ofthe present disclosure;

FIG. 1B shows an isometric view of the syringe of FIG. 1A in an expandedconfiguration;

FIG. 2A shows a front view of the syringe of FIG. 1A in the packagedconfiguration;

FIG. 2B shows front view of the syringe of FIG. 1A in the expandedconfiguration;

FIG. 3A shows a cross-sectional front view of the syringe of FIG. 1A inthe packaged configuration;

FIG. 3B shows a cross-sectional front view of the syringe of FIG. 1A inthe expanded configuration;

FIG. 4A shows a front view of a manually expandable plunger rod in apackaged configuration, according to at least one embodiment of thepresent disclosure;

FIG. 4B shows a front view of the manually expandable plunger rod ofFIG. 4A in an expanded configuration;

FIG. 5A shows a side view of the manually expandable plunger rod of FIG.4A in the packaged configuration;

FIG. 5B shows a side view of the manually expandable plunger rod of FIG.4A in the expanded configuration;

FIG. 6A shows a cross-sectional front view of the manually expandableplunger rod of FIG. 4A in the packaged configuration;

FIG. 6B shows a cross-sectional front view of the manually expandableplunger rod of FIG. 4A in the expanded configuration;

FIG. 7A shows a cross-sectional side view of the manually expandableplunger rod of FIG. 4A in the packaged configuration;

FIG. 7B shows a cross-sectional side view of the manually expandableplunger rod of FIG. 4A in the expanded configuration;

FIG. 8A shows a cross-sectional front view of an automaticallyexpandable plunger rod in a packaged configuration, according to atleast one embodiment of the present disclosure; and

FIG. 8B shows a cross-sectional front view of the automaticallyexpandable plunger rod of FIG. 8A in an expanded configuration.

DETAILED DESCRIPTION

The embodiments of the present invention provide expanding plunger rodswhich enable smaller packaging footprints (i.e., dimensions) whilemaintaining the usability necessary of plunger rods for syringes.Because the plunger rods of the present invention are expandable from afirst position to a second or subsequent final position, they areinitially capable of being assembled, packaged, transported, and storedin smaller packages, but are capable of expanding when desired for usefor drug delivery. The plunger rods of the present invention are capableof being integrated and utilized within syringes for drug delivery.

Referring to FIGS. 1A and 1B, an embodiment of a syringe assembly 50having an expanding plunger rod 100, according to at least oneembodiment of the present invention, is shown. FIG. 1A shows the syringe50 and expanding plunger rod 100 in the packaging, i.e., non-expanded,configuration, and FIG. 1B shows the syringe and expanding plunger rodin the expanded configuration. Such a syringe comprises a barrel 52having plunger end 54 and connection end 56. The barrel 52 issubstantially cylindrical in shape and is preferably formed of glass. Atthe plunger end 54 of the barrel 52 is located a collar 58 having arelease ring 59. The collar 58 may be mounted, glued, fitted orintegrally formed with the barrel 52. In embodiments where barrel 52 isformed of glass, the collar 58 is glued or otherwise adhered to thebarrel. In alternative embodiments where the barrel 52 is formed ofplastic or other moldable material, the collar 58 may be formedintegrally with the barrel (e.g., by molding). At the connection end 56of the barrel 52 is mounted a barrel tip adapter 60 (e.g., luerconnection adapter) (see FIGS. 3A and 3B) and a tip cap 78. The syringe50 further comprises a plunger seal 80 mounted thereto. The barrel 52further comprises an inside wall 64 which, together with a needle seal66 and the plunger seal 80 defines a fluid compartment 68 inside thebarrel 52. In some embodiments, the needle seal 66 is mounted or locatedat least partly within the barrel 52 and/or a mounting member 70 (seeFIGS. 3A and 3B). Accordingly, the needle seal 66 may be a component ofa needle assembly, in at least one embodiment, for mounting to a barrel52. The resulting syringes of the present disclosure which areconfigured to incorporate the expanding plunger rods 100 have thecapability of integration into standard fill-finish filling andprocessing systems currently utilized by drug fillers and pharmaceuticalcompanies, the ability to connect or engage with a range of needleassemblies and needle-less access devices (“NLADs”) such as intravenouslines, the ability to prevent or minimize clogging or breakage of theconnection between the syringe (or components thereof) and needleassemblies or NLADs, and the configurability of the syringes to providedrug delivery to a variety of target locations including subcutaneousand intramuscular.

Referring now to FIGS. 2A and 2B, in use the plunger seal 80 is movableaxially into the fluid compartment 68 in the direction of the solidarrow 62 to facilitate delivery of fluid contents of the syringe 50. Insome embodiments, the fluid compartment 68 is prefilled with fluidcontents to be delivered by the syringe 50. In this context, by“prefilled” is meant that the syringe 50 is provided to the user filledwith deliverable fluid contents without the need for the user to fillthe barrel 52 with the fluid contents.

As shown in FIGS. 3A and 3B, an adapter 60 and a mount 70 utilize aconnection 72, such as a luer connection having a tapered/conical aspectand/or a screw-threaded mating configuration. When utilizing both a luerand a screw-threaded configuration, this connection may be akin to orknown as a luer-lock connection. The connection adapter 60 is typicallyglued or otherwise firmly affixed inside the connection end 56 of thebarrel 52. The adapter 60 can have a male luer fitment 74 which extendsdistally from the connection end 56 of the barrel 52. The male luerfitment 74 is generally tubular and is formed with a center bore 76 orcentral fluid passageway extending from the fluid compartment 68 withinthe barrel 52 to the forward tip of the male luer fitment 74. Theoutside surface of the male luer fitment is tapered along the extendinglength to provide a surface sealingly mateable with the inner taperedsurface of a female luer connector. For example, the female luerconnector may be in the hub of a sharp needle assembly or as part of afluid line, such as an intravenous fluid line, connection (notillustrated). The tapered male luer fitment 74 establishes a seat forand seals with the female luer hub. Notably, the center bore 76 orcentral fluid passageway may be dimensioned to meet the necessary ordesired requirements of the particular fluid and/or delivery mechanism.In the embodiment shown in FIGS. 2A, 2B, 3A, and 3B, a tip cap 78 ismounted to the connection end 56 of the barrel 52. In other embodiments,a needle assembly or replaceable needle assembly can be mounted orremovably mounted to the adapter 60 or mount 70.

FIGS. 3A and 3B show cross-sectional front views of the syringe 50 witha manually expandable plunger rod 100 in the packaged configuration(FIG. 3A) and the expanded configuration (FIG. 3B), according to atleast one embodiment of the present invention. The relatively shortlength of the expanding plunger rod 100 in the packaged configurationmay be utilized to optimize package size, but allow for normal use uponremoval from packaging and expansion into the expanded configuration.The plunger rod 100 may be configured to connect to the plunger seal 80which, together, are slidable within a the fluid chamber 68 of a syringebarrel 52 to push or deliver a drug dose delivery to a patient. Thecomponents of the expanding plunger rod 100 are nested into one anotherand configured to slidably expand and lock into place with respect toone another to reach the fully expanded dimension. In some embodiments,in the expanded configuration, the expanding plunger rod 100 is wider atthe interface between the plunger rod and the barrel 52 than at the topend adjacent a top piece 106. Such a configuration helps limit wobblingand radial movement of the expanding plunger rod 100 in the expandedconfiguration and as the plunger rod is pushed into the barrel 52. Theplunger rods 100 may be expanded with or without a tip cap, needleassembly, NLAD, or other mount connected to the mounting member at theconnection end 56 of the barrel 52.

In one embodiment, the expanding plunger rod 100 comprises one or morenested sleeves configured to slide upon or within each other from thepackaged configuration to the expanded configuration, and to lock inplace upon reaching the expanded configuration. FIGS. 4A and 4B showfront views of the expanding plunger rod 100 in the packagedconfiguration (FIG. 4A) and the expanded configuration (FIG. 4B). Theexpanding plunger rod 100 includes an outer sleeve 110, an inner sleeve112, and an inner rod 114 all configured to nest within one another inthe packaged configuration. In the packaged configuration, shown in FIG.4A, the expanding plunger rod 100 has a relatively short length comparedto the length of the plunger rod in the expanded configuration shown inFIG. 4B. In some embodiments, the outer sleeve 110 has a larger diameterthan the inner sleeve 112, which has a larger diameter than the innerrod 114.

The outer sleeve 110 can have a closed-off bottom end 108 that canengage with the plunger seal 80 of the syringe 50 via a threaded portion109. The inner rod 114 can have a top piece 106 disposed at an upper end140 of the inner rod opposite the outer sleeve 110 and the inner sleeve112. A user can pull on the top piece 106 to move the expanding plungerrod 100 from the packaged configuration to the expanded configuration.Top piece 106 may be an integrally formed portion of inner rod 106 or,alternatively, may be a separate component attached thereto. The outersleeve 110 can have pull-back lockout tabs 120 that may be utilized toprevent pull-out of the expanding plunger rod 100 from the plunger end54 of the barrel 52. When installed in a barrel, such as in FIGS. 3A and3B, the lockout tabs 120 can engage with the releasing ring 59 (orcollar 58 thereof) to prevent excess axial movement of the expandingplunger rod with respect to the barrel 52.

FIGS. 5A and 5B show side views of the expanding plunger rod 100 in thepackaging (FIG. 5A) and expanded (FIG. 5B) configurations. As seen fromthe side, the outer sleeve 110 can include a pair of pull-back lockouttabs 120, each opposite one another. The pull-back lockout tabs 120extend radially outside the circumference of the remainder of the outersleeve 110 so as to engage with the releasing ring 59.

The expanding plunger rod 100 may further include one or more expandingguide mechanisms, stop mechanisms, and locking mechanisms that helpguide the expansion of the plunger rod, prevent the expanding plungerrod from returning to the packaged configuration after being moved intothe expanded configuration, and help prevent removal of the plunger rodfrom the barrel 52. In some embodiments, the lockout aspects work bysnapping into orifices in the outer and inner sleeves 110, 112. Thevarious guide and locking mechanisms are best seen with generalreference to FIGS. 5A, 5B, 6A, and 6B.

FIGS. 5A and 5B show side views of the expanding plunger rod 100 in thepackaging (FIG. 5A) and expanded (FIG. 5B) configurations, while FIGS.6A and 6B show cross-sectional front views of the expanding plunger rod100 in the packaged configuration (FIG. 6A) and the expandedconfiguration (FIG. 6B). The outer sleeve 110 includes a pair of outerguide slots 116 formed on either side of the outer sleeve. As seen inFIGS. 5A and 5B, the outer guide slots 116 run longitudinally along arelatively large portion of the outer sleeve 110 between the bottom end108 and an open upper end 111. The outer sleeve 110 also includes a pairof outer lock orifices 118 formed into either side of the outer sleeve.The outer lock orifices 118 are disposed between the outer guide slots116 and the upper end 111 of the outer sleeve, and are longitudinallyaligned with the outer guide slots. In other embodiments, the outer lockorifices are not aligned with the outer guide slots.

The inner sleeve 112 is configured to travel axially within the outersleeve 110 and has a lower end 122 and an upper end 124. When in thepackaged configuration, the lower end 122 can rest against the bottomend 108 of the outer sleeve 110. The lower end 122 of the inner sleeve112 includes a pair of inner sleeve stops 126 disposed on either side ofthe inner sleeve that extend radially outward at least partially throughthe outer guide slots 116 of the outer sleeve 110. When the expandingplunger rod 100 is expanded, the inner sleeve stops 126 ride upwardwithin the outer guide slots 116 as the inner sleeve 112 moves upwardwith respect to the outer sleeve 110. Upward movement of the innersleeve 112 with respect to the outer sleeve 110 is halted when the innersleeve stops 126 abut the top ends of the outer guide slots 116, asshown in FIGS. 5B and 6B.

The inner sleeve 112 also includes a pair of inner sleeve locks 128disposed on either side of the inner sleeve. In the packagedconfiguration shown in FIGS. 5A and 6A, the inner sleeve locks 128extend radially outward from the inner sleeve 112 and into the outerguide slots 116. The inner sleeve locks 128 each have a ramped upperportion 130 and a substantially flat lower portion 132. As the innersleeve 112 moves upwards with respect to the outer sleeve 110 when theexpanding plunger rod 100 expands, the inner sleeve locks 128 rideupward through the outer guide slots 116. As the ramped upper portions130 encounter the upper ends of the outer guide slots 116, the rampedupper portions are forced radially inward. When the inner sleeve locks128 reach the outer lock orifices 118 of the outer sleeve 110, the innersleeve locks are biased radially outward into the outer lock orifices.The flat lower portions 132 of the inner sleeve locks 128 can then abutthe lower ends of the outer lock orifices 118, preventing the innersleeve 112 from moving downward with respect to the outer sleeve 110,such as is shown in FIG. 6B.

The inner sleeve 112 includes a pair of inner lock orifices 134 formedinto the inner sleeve between the inner sleeve locks 128 and the upperend 124 of the inner sleeve. The inner sleeve 112 also includes a pairof stop tabs 136 disposed on either side of the inner sleeve between theinner lock orifices 134 and the upper end 124 of the inner sleeve. Thestop tabs 136 are configured so as to be biased radially inward againstthe inner rod 114 when the expanding plunger rod 100 is in the packagedconfiguration, as shown in FIG. 6A.

The inner rod 114 is configured to travel axially within the innersleeve 112 and has a lower end 138 and an upper end 140. When in thepackaged configuration, the lower end 138 can rest against the bottomend 108 of the outer sleeve 110, and the top end 140 connected to thetop piece 106 extends out of both the upper end 111 of the outer sleeve110 and the upper end 124 of the inner sleeve 112. The lower end 138 ofthe inner rod 114 includes a pair of inner rod locks 142. The inner rodlocks 142 each have a ramped upper portion 144 and a substantially flatlower portion 146. In the packaged configuration, the inner rod locks142 fit within the lower end 122 of the inner sleeve 112. As theexpanding plunger rod 100 is expanded, the inner rod 114 moves upwardwith respect to the inner sleeve 112. In some embodiments, the interiorsurface 133 of the inner sleeve 112 can have a tapered portion 131 thattapers inwardly between the inner sleeve locks 128 and the inner lockorifices 134. As the inner rod locks 142 move upward through the taperedportion 131 of the inner sleeve 112, the interior surface of the innersleeve can press against the ramped upper portion 144, forcing the innerrod locks 142 radially inward. When the inner rod locks 142 reach theinner lock orifices 134, the inner rod locks snap into the innerorifices. Thus, in the expanded configuration, as shown in FIG. 6B, theinner rod locks 142 extend radially outward into the inner lock orifices134, and the flat lower portions 146 of the inner rod locks 142 abut thelower end of the inner lock orifice to prevent the inner rod 114 frommoving downward with respect to the inner sleeve 112.

The inner rod 114 includes a pair of inner rod stops 148 formed intoeither side of the inner rod between the inner rod locks 142 and theupper end 140 of the inner rod. The inner rod stops 148 aresubstantially flat and face generally upward toward the upper end 140 ofthe inner rod 114. The inner rod 114 also has two substantially flatwall portions 150 on either side of the inner rod between the inner rodstops 148 and the upper end 140 of the inner rod. In the packagedconfiguration shown in FIG. 6A, the stop tabs 136 of the inner sleeve112 press radially inward against either flat wall portion 150. As theexpanding plunger rod 100 is expanded and the inner rod 114 moves upwardwith respect to the inner sleeve 112, the stop tabs 136, which arebiased inward, slide against the flat wall portion 150 until the stoptabs encounter the inner rod stops 148. In the expanded configuration,such as is shown in FIG. 6B, the stop tabs 136 abut the inner rod stops148, preventing the inner rod 114 from being pulled further axiallyupward with respect to the inner sleeve 112.

In some embodiments, anti-rotation ribs may also be utilized to preventthe plunger rod components (sleeves, etc.) from rotating with respect toone another. In some embodiments, a shroud may be utilized to preventthe user from delivering or releasing drug dose before the plunger rod100 is fully expanded. In the illustrated embodiment, the outer sleeve110 is configured to engage the plunger seal 80 (or stopper). In analternative embodiment, however, a sleeve other than an outer mostnested sleeve (e.g., an inner most sleeve or any other sleeve) can beconfigured to engage a plunger seal (or stopper). It should beunderstood that, although the illustrated embodiments tend to show pairsof locking and guiding aspects on opposite sides of the expandingplunger rod 100, it is contemplated that more or fewer locking andguiding aspects can be used in other embodiments. Further, in someembodiments, other lockout components may be utilized to prevent theplunger from being depressed in the distal direction after use toprohibit re-use. Although shown with two expanding sleeves, it iscontemplated that the expanding plunger rod may have any number ofsleeves. For example, the expanding plunger rod may consist of an innerrod disposed in a single sleeve. Alternatively, the plunger rod mayinclude three or more sleeves.

FIGS. 7A and 7B show cross-sectional side views of the expanding plungerrod 100 in the packaged configuration (FIG. 7A) and the expandedconfiguration (FIG. 7B). In some embodiments, the expanding plunger rod100 includes bearings 152 disposed substantially between the interiorsurface 133 of the inner sleeve 112 and the inner rod 114. As theexpanding plunger rod 100 expands from the packaged configuration inFIG. 7A to the expanded configuration in FIG. 7B, the bearings 152 rollalong an outer surface 154 of the inner rod 114 and the interior surface133 of the inner sleeve 112. In some embodiments, the bearing 152 can berotatably disposed within bearing pockets 156 in the inner rod. Thebearings 152 can help provide a smooth, rolling interface between theinner rod 114 and the inner sleeve 112, and can help keep the inner rodproperly aligned within the inner sleeve. Recesses may be formed in theinner sleeve which may serve as tracks within which the bearings maytranslate during expansion of the plunger rod, thereby furthercontrolling the motion of the bearings. Although the embodimentillustrated in FIGS. 7A and 7B include four bearings 152, it should beunderstood that more or fewer bearings can be used in other embodiments.It is also contemplated that, in some embodiments, additional bearingscan be disposed between the outer sleeve 110 and the inner sleeve 112.

FIGS. 8A and 8B show an alternative embodiment of an expanding plungerrod of the present invention may be automatically expanding plunger rod200. Unless otherwise noted, it should be understood that the featuresof automatically expanding plunger rod 200 are substantially similar tothe features of the manually expanding plunger rod 100 described herein.FIGS. 8A and 8B show cross-sectional front views of an automaticallyexpandable plunger rod 200 in the packaged configuration (FIG. 8A) andthe expanded configuration (FIG. 8B), according to at least oneembodiment of the present invention. The automatic expanding plunger rod200 includes an outer sleeve 210, an inner sleeve 212, and an inner rod214 all configured to nest within one another in the packagedconfiguration. The outer sleeve 210 includes a closed-off bottom end(208) and an open upper end (211). The inner sleeve 212 includes a lowerend 222 and an upper end 224, and the inner rod 214 has a lower end 238and an upper end 240. The inner rod 214 includes a top piece 206 thatextends axially above the open upper end 211 of the outer sleeve 210 inthe packaging configuration, as shown in FIG. 8A. The outer sleeve 210includes a pair of outer lock orifices 218 formed on either side of theouter sleeve, and the inner sleeve 212 includes a pair of inner sleevelocks 228 disposed on either side of the inner sleeve. The inner sleeve212 also includes a pair of inner lock orifices 234 formed on eitherside of the inner sleeve, and the inner rod 214 includes a pair of innerrod locks 242 disposed on either side of the inner rod. In the expandedconfiguration, the inner sleeve locks 228 extend radially outward intothe outer lock orifices 218, and the inner rod locks 242 extend radiallyoutward into the inner lock orifices 234 so as to prevent transitionfrom the expanded configuration to the packaged configuration.

The user may activate the automatic expanding plunger rod 200 by, forexample, pushing, twisting, pulling, or another action/combination ofactions that releases a device that causes a biasing member 280, such asa spring, to expand the plunger rod 200 automatically. In theillustrated embodiment, the biasing member 280 is disposed axiallywithin the inner rod 214, an inner sleeve 212, and the outer sleeve 210.The biasing member can be any device which can store energy in areleasable form, such as a spring (e.g., a coil spring, leaf springetc.) elastic or the like. Although only one biasing member 280 is shownin the embodiment shown in FIGS. 8A and 8B, it is contemplated thatother embodiments could use multiple biasing members to automate theexpansion of the expanding plunger rod 200. In the embodiment shown inFIGS. 8A and 8B, the biasing member 280 is configured to push on the toppiece 206 of a inner rod 214 and a bottom end 208 of the outer sleeve ofthe expanding plunger rod 200. The biasing member 280 forces theexpanding plunger rod open (i.e., to expand) once automatic expansion isactivated by the user. In at least one embodiment, the outer most nestedsleeve 210 is configured to engage a plunger seal (or stopper). In analternative embodiment, however, a sleeve other than the outer mostnested sleeve (e.g., the inner most sleeve or any other sleeve) isconfigured to engage a plunger seal (or stopper).

In one embodiment, a platform may be utilized to prevent any load orforce from the spring to be transferred to the plunger seal. Theplatform may help to limit or prevent premature drug delivery and/ordrug loss. In such embodiments, the biasing member may be completelyinternal and the platform or tab may be removable by the user, forexample, after the automatic expansion of the plunger rod has occurredand the expanding plunger rod is locked into its expanded configurationfor drug dose delivery. Alternatively, the tab or platform may yield ata given point and/or may be moved, such as moved radially, to clear thepath for axial plunger rod travel during drug delivery.

The embodiments of the present invention may further utilize additionalcomponents to enhance the use of the syringe. For example, the syringemay incorporate tamper-resistance aspects to prevent tampering of thesyringe. These tamper-resistance aspects deter or prevent a user from,for example, removing the plunger rod and/or providing evidence oftampering to the user. These tamper-resistance aspects could be locatedalong the plunger rod, plunger seal, and/or the barrel flange, collar,and/or release ring. These tamper-resistance aspects could be axiallypositioned and/or longitudinally oriented, or in a number of other knownconfigurations. In one embodiment, the tamper-resistance aspects may betamper tabs. These tamper-resistance aspects impact upon the barrelflange, collar, and/or release ring to prevent pulling the plunger rodout of the barrel in the proximal direction. The tamper-resistanceaspects may additionally or alternatively be located on an optionalstability ring or flange of the plunger rod. Optionally, the syringes ofthe present invention may utilize tamper-evident features. For example,the syringes and/or adapters may utilize an over-sized orspecially-shaped tip cap that cannot be reinserted into the syringeafter removal. Alternatively, the syringes and/or adapters may utilizetamper tabs that connect the tip cap to itself through a window in theadapter during assembly, but cannot be reassembled. As a furtherembodiment, the tip cap or tip cap assembly may be bonded to the barreltip during assembly, and a broken bond could be utilized to providevisual indication of tampering.

The connection adapters of the present invention may utilize a lockingaspect that is incorporated, for example, into a standard luer threadpattern. This configuration may be utilized to lock an attachment, suchas a needle assembly, to the syringe via the adapter. The locking aspectand/or lock feature(s) may alternatively, or additionally, be internalto the adapter. Such locking aspects and adapters may be utilized with aproprietary connection and/or a luer connection. The figures show theattachment of the adapter to a straight barrel, such as a straight glassbarrel, but this can also be utilized to attach to a tapered orformed-shape barrel. The adapter may have a ledge to facilitate easymounting and attachment (such as by glue or adhesive) to the distal endof a barrel. An internal window ledge may be utilized for needle sealattachment, and also to prevent movement of the needle seal.

In some embodiments, the invention provides a retractable syringe kitcomprising a barrel, a plunger and a plurality of replaceable needleassemblies. In one embodiment of the retractable syringe kit, theplurality of needle assemblies comprise a 0.5 inch needle, a 1.0 inchneedle, and a 1.5 inch needle, though a range of needle lengths andgauges may be utilized and incorporated within the needle assemblies andkits of the present invention.

In a particular embodiment, the retractable syringe kit furthercomprises a vial adapter. In one particular form, the vial adaptercomprises a housing having a base, an adapter cannula that extends orprojects from the base and a connector that is capable of being in fluidcommunication with fluid contents of a vial and the barrel of saidretractable syringe, the adapter housing further comprising a shroud toprotect a user from inadvertent needle-stick injury by said adaptercannula, said shroud comprising one or more arms that engage a vialclosure. The shroud may further comprise one or more flexion arms thatallow the vial adapter to engage any of a variety of different-sizedvial closures. In use, the vial adapter facilitates transfer or deliveryof fluid between the vial and the syringe barrel to thereby allow fluidreconstitution of a powdered, dried, desiccated or dehydrated solidsubstance contained within the syringe barrel or within the vial.

In one embodiment, the invention provides a method of assembling asyringe including the step of inserting or attaching the expandingplunger rod to the proximal end of a barrel of a syringe. Optionally, areleasing ring and/or a collar may be present on the proximal end of thebarrel for engagement with the plunger rod. The method of assembly mayfurther include the step of connecting the expanding plunger rod to aplunger seal. Preferably, the method includes the step of removing aplug from a mounting member of the barrel prior to removably mountingthe replaceable mount to the barrel. In one embodiment, the methodincludes the step of screw-threadedly mounting a mount of a needleassembly or NLAD to a mounting member of the barrel.

In developing syringes with needle safety mechanisms, relativelycomplicated component assemblies have been utilized which addsubstantially to the complexity and cost of manufacture. Additionally,existing configurations may not adequately address challenges relatedto: patient and user safety needs, user ease-of-operation, and drugfiller or pharmaceutical company operational systems, among others. Indeveloping a selectable needle safety syringe having a retractionplunger, the inventors of the present invention have addressed thesechallenges and others without comprising the manufacturability,stability, and durability of the devices.

Additionally, in providing a means for selectable attachment of varyingneedle assemblies, the present invention provides configurations thatare capable of being adapted for a broad range of drug barrel (i.e.,primary container) types. Existing devices possess relativelycomplicated luer assemblies have been devised which often are adaptedfor a particular syringe barrel shape or configuration and cannot bereadily mounted to a syringe barrel having a different shape orconfiguration. This is particularly a problem with glass syringe barrelswhich are generally in short supply, many of which glass barrels do nothave a desired shape or configuration for mounting a luer assembly.Alternatively, the syringes may be manufactured with a pre-formed luerassembly. However this adds substantial complexity and cost to theprocess for manufacture of such syringes.

Each of the embodiments described herein may be used alone or incombination with one or more other embodiments in a syringe. Throughoutthe specification, the aim has been to describe the preferredembodiments of the invention without limiting the invention to any oneembodiment or specific collection of features. Various changes andmodifications may be made to the embodiments described and illustratedwithout departing from the present invention. The disclosure of eachpatent and scientific document, computer program and algorithm referredto in this specification is incorporated by reference in its entirety.

1. An expanding plunger rod for a syringe, the expanding plunger rodconfigured to transition from a packaged configuration for packaging toan expanded configuration for operation, the expanding plunger rodcomprising: a substantially cylindrical outer sleeve having a closed-offbottom end and an open upper end; and an inner rod having a lower endand an upper end, the inner rod being slidably disposed coaxially withinthe outer sleeve; wherein, in the packaged configuration, the inner rodis nested within the outer sleeve; and wherein, in the expandedconfiguration, the inner rod is disposed substantially axially above theouter sleeve, and the inner rod is configured to lock axially in placeso as to prevent transition from the expanded configuration to thepackaged configuration.
 2. The expanding plunger rod of claim 1, whereinthe outer sleeve includes a first locking mechanism and the inner rodincludes a second locking mechanism, and wherein, in the expandedconfiguration, the first locking mechanism is engaged with the secondlocking mechanism so as to prevent transition from the expandedconfiguration to the packaged configuration.
 3. The expanding plungerrod of claim 1, wherein the closed bottom end of the outer sleeve isconfigured to connect to a plunger, the outer sleeve and the plungerseal being slidable within a fluid compartment of the syringe.
 4. Theexpanding plunger rod of claim 1, further comprising an inner sleevehaving a lower end and an upper end, the inner sleeve being slidablydisposed coaxially within the outer sleeve and the inner rod beingslidably disposed within the inner sleeve, wherein, in the expandedconfiguration, the upper end of the inner sleeve and the lower end ofthe inner rod are disposed axially above the open upper end of the outersleeve.
 5. The expanding plunger of claim 4, wherein the outer sleeveincludes a first stop mechanism, the inner sleeve includes a second stopmechanism and a third stop mechanism, and the inner rod includes afourth stop mechanism, wherein, in the expanded configuration, the firststop mechanism is engaged with the second stop mechanism and the thirdstop mechanism is engaged with the fourth stop mechanism so as toprevent further axial travel of the inner sleeve and the inner rod awayfrom the outer sleeve.
 6. The expanding plunger rod of claim 4, whereinthe outer sleeve includes a first locking mechanism, the inner sleeveincludes a second locking mechanism and a third locking mechanism, andthe inner rod includes a fourth locking mechanism, and wherein, in theexpanded configuration, the first locking mechanism is engaged with thesecond locking mechanism and the third locking mechanism is engaged withthe fourth locking mechanism so as to prevent transition from theexpanded configuration to the packaged configuration.
 7. The expandingplunger rod of claim 1, wherein the outer sleeve further comprises apull-back lockout tab that is configured to prevent removal of the outersleeve from a barrel of the syringe.
 8. A syringe assembly configured totransition from a packaged configuration for packaging to an expandedconfiguration for operation, the syringe comprising: a substantiallycylindrical barrel having a plunger end and a connection end; a plungerseal disposed within the plunger end of the barrel; a needle sealdisposed within the connection end of the barrel; a fluid compartmentdefined within the barrel between the plunger seal and the needle seal;and an expanding plunger rod comprising: a substantially cylindricalouter sleeve having a closed-off bottom end connected to the plunger,and an open upper end, an inner sleeve having a lower end and an upperend, the inner sleeve being slidably disposed coaxially within the outersleeve, and an inner rod having a lower end and an upper end, the innerrod being slidably disposed coaxially within the inner sleeve; wherein,in the packaged configuration, the inner sleeve and the inner rod areboth nested within the outer sleeve; and wherein, in the expandedconfiguration, the upper end of the inner sleeve and the lower end ofthe inner rod are both disposed axially above the open upper end of theouter sleeve, and the inner sleeve and inner rod are configured to lockaxially in place so as to prevent transition from the expandedconfiguration to the packaged configuration.
 9. The syringe assembly ofclaim 8, wherein the outer sleeve includes a first locking mechanism,the inner sleeve includes a second locking mechanism and a third lockingmechanism, and the inner rod includes a fourth locking mechanism, andwherein, in the expanded configuration, the first locking mechanism isengaged with the second locking mechanism and the third lockingmechanism is engaged with the fourth locking mechanism so as to preventtransition from the expanded configuration to the packagedconfiguration.
 10. The syringe assembly of claim 8, wherein the outersleeve and the plunger seal are slidable within the fluid compartment ofthe syringe to expel fluid out of the fluid compartment.
 11. The syringeassembly of claim 8, wherein the outer sleeve further comprises a stopmechanism configured to engage with the barrel so as to prevent theexpanding plunger rod from being removed from the barrel.
 12. Thesyringe assembly of claim 11, wherein the barrel further comprises acollar disposed at the plunger end of the barrel, the stop mechanism ofthe outer sleeve being configured to engage with the collar to so as toprevent the expanding plunger rod from being removed from the barrel.13. The syringe assembly of claim 9, wherein the first locking mechanismis an outer lock orifice formed into a side of the outer sleeve and thesecond locking mechanism is an inner sleeve lock disposed on a side ofthe inner sleeve, wherein, in the expanded configuration, the innersleeve lock extends radially outward into the outer lock orifice. 14.The syringe assembly of claim 13, wherein the third locking mechanism isan inner lock orifice formed into a side of the inner sleeve, and thefourth locking mechanism is an inner rod lock disposed on a side of theinner rod, wherein, in the expanded configuration, the inner rod lockextends radially outward into the inner lock orifice.
 15. The syringeassembly of claim 8, wherein the outer sleeve includes a first stopmechanism, the inner sleeve includes a second stop mechanism and a thirdstop mechanism, and the inner rod includes a fourth stop mechanism,wherein, in the expanded configuration, the first stop mechanism isengaged with the second stop mechanism and the third stop mechanism isengaged with the fourth stop mechanism so as to prevent transitionfurther axial travel of the inner sleeve and the inner rod away from theouter sleeve.
 16. An expanding plunger rod for a syringe, the expandingplunger rod configured to transition from a packaged configuration forpackaging to an expanded configuration for operation, the expandingplunger rod comprising: a substantially cylindrical outer sleeve havinga closed-off bottom end and an open upper end; an inner rod having alower end and an upper end, the inner rod being slidably disposedcoaxially within the outer sleeve and including a top piece extendingaxially above the open upper end of the over sleeve; and a biasingmember disposed between the top piece of the inner rod and theclosed-off bottom end of the outer sleeve, the biasing member biasingthe top piece and the bottom end axially away from one another; wherein,in the packaged configuration, the inner rod is nested within the outersleeve, and in the expanded configuration, the inner rod is disposedsubstantially axially above the outer sleeve, and the inner rod isconfigured to lock axially in place so as to prevent transition from theexpanded configuration to the packaged configuration; and wherein thebiasing member is configured to automatically transition the expandingplunger rod from the packaged configuration to the expandedconfiguration.
 17. The expanding plunger rod of claim 16, wherein theclosed bottom end of the outer sleeve is configured to connect to aplunger, the outer sleeve and the plunger seal being slidable within afluid compartment of the syringe.
 18. The expanding plunger rod of claim16, further comprising an inner sleeve having a lower end and an upperend, the inner sleeve being slidably disposed coaxially within the outersleeve, and the inner rod being slidably disposed coaxially within theinner sleeve, wherein, in the expanded configuration, the upper end ofthe inner sleeve and the lower end of the inner rod are both disposedaxially above the open upper end of the outer sleeve.
 19. The expandingplunger rod of claim 16, wherein the biasing member is configured toautomatically transition the expanding plunger rod from the packagedconfiguration to the expanded configuration upon being triggered. 20.The expanding plunger rod of claim 18, wherein the outer sleeve includesa first locking mechanism, the inner sleeve includes a second lockingmechanism and a third locking mechanism, and the inner rod includes afourth locking mechanism, and wherein, in the expanded configuration,the first locking mechanism is engaged with the second locking mechanismand the third locking mechanism is engaged with the fourth lockingmechanism so as to prevent transition from the expanded configuration tothe packaged configuration.